CMS Finalizes TAVR Coverage Update, Adding Asymptomatic Aortic Stenosis Under Study Rules

The Centers for Medicare & Medicaid Services on Thursday finalized an updated national coverage determination for transcatheter aortic valve replacement (TAVR), extending Medicare coverage to people with severe aortic stenosis who have no symptoms, provided the procedure is done within a CMS-approved clinical study.

According to the final decision memo, posted on September 10, CMS updated the policy to cover TAVR for symptomatic severe aortic stenosis without the coverage with evidence development (CED) requirement that has applied since the 2019 decision; to expand coverage to asymptomatic severe aortic stenosis with CED; and to revise criteria for pre-procedure assessment, intraoperative requirements and procedural volume.

What the decision changes

Coverage applies only when the procedure uses a complete valve and delivery system that has FDA premarket approval for that system's approved indication. The memo keeps the heart team: at least one cardiac surgeon and one interventional cardiologist with privileges at the hospital, along with nurses, advanced practice clinicians and other staff.

Patients must receive an initial heart team evaluation that includes input from both cardiac surgery and interventional cardiology, and an in-person evaluation by a heart team TAVR operator, which the memo says cannot be done virtually. Joint participation by two operators during the procedure is no longer required but is covered if the heart team chooses it.

Volume requirements now attach to the operator. A TAVR operator must perform at least 20 transcatheter valve procedures a year, at least 15 of them TAVR, or at least 40 over two years, at least 30 of them TAVR. In its response to comments, CMS wrote that contemporary peer-reviewed studies support that operator volumes matter more than hospital volumes. Hospitals must still have on-site structural heart and cardiac surgery programs, a post-procedure intensive care unit and a continuous quality improvement process.

Asymptomatic patients and study requirements

For asymptomatic severe aortic stenosis, the procedure must be furnished in a CMS-approved CED study with an active comparator. The memo lists the questions those studies must address, including whether TAVR, surgical valve replacement or close surveillance until symptoms appear better improves health outcomes, and what long-term reintervention rates look like after TAVR. Studies must meet 17 scientific standards drawn from CMS's 2024 CED guidance.

CMS said the reconsideration of the 2019 policy was opened after a formal request from Edwards Lifesciences, maker of the Sapien valves, following the FDA's April 30, 2025 expansion of indications to include asymptomatic patients. The agency received 171 comments in the first comment period, which ran from December 15, 2025 to January 14, 2026, and posted 257 comments from the second, which followed its June 15 proposed decision. The memo states that it does not address TAVR for aortic regurgitation; without a national policy, coverage for other conditions is left to Medicare Administrative Contractors.

Industry and analyst response

As reported by MedTech Dive, Edwards said the new criteria will improve patient access, and Medtronic also welcomed the decision. Edwards said that because the policy will take time to implement, it had confidence in its previously communicated 2026 financial guidance.

MedTech Dive reported that some medical societies had argued for keeping evidence requirements for all patients after the June proposal. Analysts at BTIG told the outlet, "We see these as positive changes that can eventually increase TAVR procedure volumes." Stifel analysts estimated that TAVR accounts for about 75% of Edwards' revenue and 5.5% of Medtronic's revenue, according to the report.

CMS will implement the decision through revised manual language set out in Appendix A of the memo.